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SUDAFED PE SEVERE COLD
Cough and cold
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Drug Name:

SUDAFED PE SEVERE COLD OTC

Generic Name and Formulations:
Acetaminophen 325mg, diphenhydramine HCl 12.5mg, phenylephrine HCl 5mg; per caplet.

Company:
McNeil Consumer Healthcare

Therapeutic Use:

Indications for SUDAFED PE SEVERE COLD:

Nasal congestion, rhinorrhea, headache, sore throat, fever.

Adult:

2 caplets every 4hrs as needed; max 12 caplets/24hrs.

Children:

<6yrs: individualize. 6–11yrs: 1 caplet every 4hrs as needed; max 5 caplets/24hrs.

Contraindications:

Within 14 days of MAOIs. Concomitant acetaminophen or diphenhydramine (including topical) products.

Warnings/Precautions:

Cardiovascular disease. Hypertension. Liver disease. Thyroid disease. Glaucoma. Diabetes. Asthma. Lower respiratory disorders. GI or GU obstruction.

Interactions:

See Contraindications. Increased risk of liver damage with ≥3 alcoholic drinks/day. Hypertensive crisis with MAOIs. β-blockers may increase the pressor effects of sympathomimetics. Other CNS depressants potentiated. Antihypertensives antagonized.

Pharmacological Class:

Analgesic + antihistamine + sympathomimetic.

Adverse Reactions:

Drowsiness, anticholinergic effects, nervousness, dizziness, insomnia, excitability in children.

How Supplied:

Severe Cold—12, 24

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